Study to evaluate the safety of combivent delivered in two different formulations (hydrofluoroalkane (HFA) or chlorofluorocarbon (CFC)) from a metered dose inhaler (MDI), using a cumulative dose response model in patients with COPD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
7
Number of patients with clinically significant changes in electrocardiogram (ECG) parameters (ventricular rate, PQ, QRS, QT and QTc intervals)
Time frame: Baseline, up to 8 days after last treatment day
Number of patients with clinically significant changes in vital signs (blood pressure, puls rate, respiratory rate)
Time frame: Baseline, up to 8 days after last treatment day
Changes in intra ocular pressure (IOP)
Time frame: Baseline, up to 30 min after last drug administration
Changes in serum potassium levels
Time frame: Baseline, up to 180 min after last drug administration
Changes in serum glucose levels
Time frame: Baseline, up to 60 min after last drug administration
Number of patients with clinically significant changes from baseline in clinical laboratory evaluations
Time frame: Baseline, 8 days after last treatment day
Number of patients with adverse events including paradoxical bronchospasm
Time frame: Up to 8 days after last treatment day
Number of patients with clinically significant changes from baseline in physical examination
Time frame: Baseline, 8 days after last treatment day
Change in FEV1 (forced expiratory volume in one second)
Time frame: Baseline, up to 180 min after last drug administration
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Change in FVC (forced vital capacity)
Time frame: Baseline, up to 180 min after last drug administration